Posted in Blog on May 1, 2015
Low testosterone therapy is becoming more and more popular, with the industry now worth an estimated $2 billion as reported by Fox News. The promise of relief from symptoms related to low testosterone, such as fatigue, loss of sex drive and weight gain, has naturally attracted men who are suffering in varying degrees or looking for a bit of their lost youth.
Naturally, big pharmaceutical companies were all too ready to meet the growing demands for “Low T” medications and have since flooded the market with everything from gels to injections. However, with new research emerging and reported cases of heart-related issues resulting from Low T therapy, these medications may not be the relatively safe cure-all for middle-aged men that they’ve been advertised to be.
In February of 2014, five different lawsuits were filed against the makers of AndroGel, a Low T gel medication. Three of the plaintiffs have alleged that they suffered heart attacks as a result of using AndroGel, another claims he had a stroke, and the final plaintiff reported suffering from a mini-stroke, which is an event that briefly cuts the blood flow to the brain and may signal the future onset of a full stroke.
The ages of the men involved in the suits range from 50 years old to 63 years of age. Just days prior to the lawsuits being filed, the Food and Drug Administration announced that it would be re-addressing the side effects related to the heart from previously approved Low T therapy medications.
Two studies appeared to have prompted this decision, including a November 2013 report in the Journal of the American Medical Association that linked testosterone use to an increased risk of heart attacks and strokes.
Toward the end of February of 2014, a lawsuit was filed in California against the makers of Testim, another low testosterone therapy gel. The plaintiff alleges that Auxilium Pharmaceuticals mislead its consumers about the safety of Testim, and that he had a stroke after he was prescribed the gel to treat low testosterone levels.
During June of 2014, a federal judge in Illinois ordered that 45 pending cases in the state against the makers of various Low T medications be centralized and brought before one judge. These lawsuits involve numerous prescriptions, including Depo-Testosterone, AndroDerm and Axiron.
Most cases involved similar claims of harm from the Low T medications, including heart attacks, strokes and blood clots. In the same month, the FDA issued an edict requiring manufacturers of Low T medications to include a warning on the labeling about the risk of blood clots.
Specifically, the FDA instructed the pharmaceutical industry to make warnings more general, as the prior standards only called for a blood clot warning related to polycythemia, a condition in which red blood cell counts increase. In its release, the agency also stated this was not related to their ongoing investigation into claims of heart events because of side effects from low testosterone therapy. Learn more at: www.zanerhardenlaw.com.